Information about Military and Civilian Biodefense/Terrorism Countermeasures, vaccines, laws and policies

June 28, 2002

FEDERAL OFFICIALS ANNOUNCE ANTHRAX VACCINE POLICY

Officials from the Department of Defense and the Department of Health and Human Services announced today the highlights of a coordinated effort to react to possible, future anthrax incidents.

The coordinated efforts of the Department of Defense, the Department of Health and Human Services and other federal agencies call for reinstituting the use of the vaccine for certain service members, and for the stockpiling of both antibiotics and FDA-approved anthrax vaccine for civilians.

"Given the deadly events of last fall and what we know of the threat of anthrax as a bioweapon," said Deputy Secretary of Defense Paul Wolfowitz, "we are taking action to provide protection to those servicemembers who are at greatest risk, and also to share available vaccine supplies with the Department of Health and Human Services and other federal agencies to address possible domestic use situations. This policy coordinates and balances both civil and military needs."

Although anthrax poses an extremely lethal threat, events have shown that antibiotics have provided effective treatment if exposure is known before symptoms have appeared. Accordingly, the policy will focus on reserving stockpiles of the vaccine for emergency situations, to be used in combination with antibiotics after possible exposure. For military servicemembers in higher threat areas of the world, the vaccine will offer an additional layer of protection.

Details for the policy for domestic use are being coordinated with the Office of Homeland Security. The military policy will require mandatory protective vaccination of some troops who will be assigned to certain higher-threat areas. "Our policy for military servicemembers will focus the use of the vaccine for those at highest risk," said Wolfowitz.

"Anthrax vaccine is a critical component in our arsenal against bioterrorism and stockpiling the vaccine is the most prudent course for protecting our citizens' health and well-being," said Deputy HHS Secretary Claude Allen. "In the meantime, HHS is aggressively pursuing efforts to develop new vaccines and diagnostic tools for the disease agents most likely to be used in a bioterrorism attack, including anthrax."

HHS, DoD and other federal agencies are working vigorously to develop a new generation anthrax vaccine that is expected to offer a more user-friendly regimen than the current vaccine which requires six shots with yearly boosters. Currently, there has been strong interest from industry to develop and produce an improved vaccine, requiring fewer doses, in just a few years.

BioPort Corp., Lansing, Mich., is the only U.S. manufacturer of the anthrax vaccine. The vaccine has been licensed by the Food and Drug Administration since 1970, and due to facility and processing renovations, BioPort has undergone recent FDA review. In January of this year the FDA approved BioPort's facilities and vaccine manufacturing processes. The Department of Defense, working in coordination with other federal agencies, plans to buy the entire production output of the sole U.S. manufacturer to maximize the level of protection and treatment possible for all of our citizens.

Regarding the safety and effectiveness of the anthrax vaccine, the National Academy of Sciences' Institute of Medicine released a March 2002 report that stated, "As indicated by evidence from studies in both humans and animals, the committee concluded that AVA (the anthrax vaccine), as licensed, is an effective vaccine to protect humans against anthrax, including inhalational anthrax. Moreover, because the vaccine exerts its protection via an antigen crucial to the action of the bacterium's toxins, AVA should be effective against anthrax toxicity from all known strains of B. anthracis, as well as from any potential bio-engineered strains."